Adverse Events - Medtronic Prostiva 8930 Guía Para El Usuario

8930EN_5.fm 12/17/10 2:44 pm
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7 x 9 inches (178 mm x 229 mm)
Chapter 5
90
Overview

Adverse Events

Table 5-1. Adverse Events
Adverse Event
Obstruction
Catheterization
(for urinary retention)
Bleeding
Pain/Discomfort
Urgency
Frequency
Urinary Tract Infection
Dysuria
Scarring/Stricture
Impotence
Retrograde Ejaculation
Incontinence
a
In the lateral and median lobe studies, dysuria was described as irritative voiding symptoms, which include
pain, discomfort, or frequency.
English 8930 System User Guide 2010-12
MA07445A008 Rev X
The clinical trials demonstrated that the TUNA Procedure can be
performed without the need for general or regional (spinal)
anesthesia; however, sedation is often used. Treatment with the
TUNA Procedure is associated with few side effects and adverse
events. The following table (Table 5-1) summarizes the safety
data of patients from the original TUNA Therapy versus TURP
study (lateral lobe only) and that from the two additional studies
(P01 and PM1) that included treatment of patients having a
degree of median lobe hyperplasia.
Original Tuna
Therapy Lateral Lobe Median Lobe Study
Study
44%
41%
29%
23% (included in Dysuria)
8% (included in Dysuria)
8% (included in Dysuria)
6%
2%
<2%
<2%
<1%
0%
P01 Lateral and PM1 Lateral and
Median Lobe Study
0%
15%
9%
a
(included in Dysuria)
a
(included in Dysuria)
a
(included in Dysuria)
12%
a
15% (irritative 6%
symptoms) symptoms
0%
0%
3% (partial)
0%
Medtronic Confidential
CRMRef_R06
0%
6%
6%
a
a
a
0%
a
(irritative
0%
0%
0%
0%